Artificial Disc Replacement

Artificial Disc Replacement is designed to:

• Maintain motion in the spine at the area of implantation
• Maintain stability
• Restore proper disc height
• Restabilize alignment
• Decrease discogenic pain
• Inclusion Criteria:
• Suffer from low back pain
• Be between 18 and 60 years of age
• Have a diagnosis of Degenerative Disc Disease at a single level between L1 and S1
• Have had at least six months of prior conservative treatment
• Exclusion Criteria:
• Any previous back fusion surgery
• Multiple levels of degenerative disc disease
• Osteoporosis, osteopenia or other metabolic bone disease
• Infection, spinal stenosis, spondylolisthesis, scoliosis or spinal tumor
• History of chronic steroid use
• Pregnancy or morbid obesity

FlexiCore Artificial Disc:

FlexiCore is a metal-on-metal device that is inserted as a single unit. The superior and inferior portions are linked by a captured ball-and-socket joint. The FlexiCore can be implanted from a straight anterior or an anterolateral direction, and offers the ability to manipulate the position of the implant within the intervertebral space. Unique domed baseplate surfaces are shaped to approximate the concavities of the vertebral body endplates, and are coated with titanium plasma spray to assist bone on growth fixation.

In the US FDA IDE study, FlexiCore was randomized to an anterior-posterior (360) fusion with anterior bone graft and posterolateral fusion using pedicle screws.  Patients with single-level disc disease were studied. The randomized study has been completed, and Flexicore is now in Continued Access mode.

The FlexiCore™ Intervertebral Disc is an investigation device. The government requires that new devices be investigated for safety and effectiveness before they can be made generally available. This study is designed to determine if symptom relief provided by the FlexiCore disc is better, worse, or the same as a fusion surgery. Additionally, it is to determine if patients with the FlexiCore disc will still have motion of their vertebrae, compared with patients undergoing fusion (who should have very little or no motion at the fusion site).

• Initial Phase of Clinical Trial
• Second Phase of Clinical Trial
• Procedure - The FlexiCore Artificial Disc Replacement involves making an incision in the abdomen and removing a single damaged disc between the vertebra. The disc tissue is replaced with the FlexiCore Intervertebral Disc utilizing a distraction device to adequately place the disc in position. The vertebra are not fused in this procedure, which will allow motion at the operated disc space post operatively.

For more information on the FlexiCore Artificial Disc, visit www.stryker.com.

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